J4G-MC-JZVD - FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Untreated Locally Advanced or Metastatic Urothelial Carcinoma with an FGFR3 Genetic Alteration.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522855-25-00

Enrollment

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Neoplasm Metastasis, Transitional Cell, Urinary Bladder Neoplasms

Brief summary

Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab, Safety Lead-in:Overall Response Rate (ORR), Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)

Interventions

DRUGPEMBROLIZUMAB

DRUGPlacebo to match ly

DRUGENFORTUMAB VEDOTIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab, Safety Lead-in:Overall Response Rate (ORR), Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 22, 2026